Research Ethics & Compliance Dr Simon Barrett Manager, Research Ethics & Compliance Monash Research Office

Legislation:  Prevention of Cruelty to Animals Act 1986  NHMRC Act 1992  ARC Act 2001  Prohibition of Human Cloning Act 2002  Research Involving Human Embryo Act 2002  Gene Technology Act 2000  Quarantine Act 1908  National Health Security Act 2007  Privacy Act 2000

Codes of Practice  NHMRC & ARC –Australian Code for the Responsible Conduct of Research –Australian Code of Practice for the Care and Use of Animals for Scientific Purpose –The National Statement on Ethical Conduct in Human Research –Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research ………………………………………….And many more

Review Processes  Monash University Human Research Ethics Committee  Animal Ethics Committees (10 x local)  Monash University Institutional Biosafety Committee

What is Human Research?  Taking part in surveys, interviews or focus groups  Undergoing psychological, physiological or medical testing or treatment  Being observed by researchers  Researchers having access to personal documents or other materials  Collecting organs, tissues, fluids or exhaled breath  Access to information (individually identifiable, re-identifiable or non-identifiable) as part of an existing published or unpublished source or database

Risk and Benefit  benefits justify the risks  level of ethical review should reflect the level of risk

Consent  Participation is voluntary  Consent must be informed –Sufficient information to understand the purpose, demands, risks and potential benefits.

Applications:  “Low Risk” Research (Form LR) ~ 2 weeks  Greater than “Low Risk” Research (Form 1) ~ 8 weeks  Multi Centre ~ 1 week

Animal Ethics Review:  All Monash scientific activities (teaching or research) using animals requires approval from a Monash AEC before work can commence.

Animal Welfare General Principles:  Justification  Responsibilities  Replacement  Reduction  Refinement

Applications:  Applications are made to local AEC  Must be reviewed by full committee in “face to face” meeting.  Application usually require amendments  Often approved once amendments are received by secretary and reviewed by chair.  Average approval ~ 60 days

Gene Technology (GT) Act, 2000  Introduces a national scheme for the regulation of GMOs in Australia  Protect the health and safety of Australians and the environment  Identify and manage the risks posed by or as a result of gene technology

Requirements of the GT Act  Organisations undertaking dealings are “Accredited”  Dealings are classified based on their level of risk –Exempt –Notifiable Low Risk Dealings –Licensed (non-intentional release & intentional release)  Facilities for certain “Dealings” are “Certified”

Applications:  Application received at anytime.  Approvals –Exempt - immediate –Notifiable Low Risk Dealings ~ 2 weeks –Dealings Not Involving Release or Dealings Involving Release must await approval from OGTR ~ up to 90 business days

Quarantine Act 1908 (Regulations 2000)  Controls Australia’s borders to minimise the risk of exotic pests and diseases to agriculture industries and the environment  Import and Export Inspection and Certification  Australia is currently free from a number of biological threats, such as foot and mouth disease, that have had major economic and environmental consequences for other countries

Import Permits Import permits are required for the following examples of goods: –Human/animal tissue, blood, fluid, sera samples –Cell lines –Laboratory Reagents Eg. Proteins, peptides, lipids, hormones, enzymes, etc. –Genetic Material –Micro-organisms –Antibodies/antiserum –Diagnostic Kits Eg. ELISA kits –Soil/water samples –Plants –Animals (including insects)

Import Permits  Allows researchers to import goods which are subject to quarantine  Contains post entry conditions requiring that the goods be restricted to specified quarantine facilities, also known as Quarantine Approved Premises (QAPs)  Specifies the level of containment required for the goods  ALL import permits for the University are now applied for through the Research Compliance Office

Funding Bodies  Requirement of clearances –Funds aren’t released until clearance approvals have been sited.  Code for the Responsible Conduct of Research –“Compliance with the code is a prerequisite for the receipt of NHMRC and ARC funding”

What you need to know. That……  Approvals for you work are in place  You names are added to any existing or new approvals  Be familiar with the content of the approved application  Be familiar with any conditions of approval…..and comply with them